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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, C-Reactive Protein
510(k) Number K902593
Device Name RAICHEM(TM) SPIA(TM) CRP REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Applicant Contact NEUMANN, PHD
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Correspondent Contact NEUMANN, PHD
Regulation Number866.5270
Classification Product Code
DCN  
Date Received06/12/1990
Decision Date 06/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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